Patient-Focused Medical Product Development Webinar Series The NHC’s Patient-Focused Medical Product Development series builds upon our Clinical Outcome Assessment (COA) series, which we hosted between Nov. 2018-Dec. 2019. The series […]
FDA regulations
Webinar: Perspectives on the FDA’s 2nd Patient-Focused Drug Development Guidance
Webinar: Perspectives on the FDA’s 2nd Patient-Focused Drug Development Guidance The National Health Council and our member organizations present a webinar on the FDA’s second draft guidance in their series […]
2019 Washington Representatives Retreat
2019 Washington Representatives Retreat Each year, the National Health Council (NHC) hosts the Washington Representatives Retreat, a two-day event to gather staff from NHC member organizations to address strategic, operational, and […]
Patient-Reported Outcomes in Orphan Drug Labels Approved by the US Food and Drug Administration
Dr. Eleanor Perfetto, NHC Executive Vice President, Strategic Initiatives, co-authored a paper titled, “Patient-Reported Outcomes in Orphan Drug Labels Approved by the US Food and Drug Administration,” which was published […]
The Sentinel System— An Overview of FDA’s Tools for Assessing Medical Product Safety and Gathering Real-World Evidence
The Sentinel System— An Overview of FDA’s Tools for Assessing Medical Product Safety and Gathering Real-World Evidence This webinar provided an overview of Sentinel’s growing capabilities and value in regulatory […]
Food and Drug Administration’s (FDA’s) Draft Guidance on Enhancing the Diversity of Clinical Trial Populations
The National Health Council (NHC) appreciates the opportunity to provide comments on the Food and Drug Administration’s (FDA’s) draft guidance on Enhancing the Diversity of Clinical Trial Populations. While industry […]
Webinar Preview: Perspectives on the FDA’s 2nd Patient-Focused Drug Development Guidance
By Maddie Mason, Associate, Policy On Friday, Dec. 13 from 2 – 3 p.m. ET/ 11 a.m. – noon PT, the National Health Council (NHC) and our member organizations will […]
FDA’s Roadmap to Patient-Focused Outcome Measurement in Clinical Trials
By Elisabeth M. Oehrlein, PhD, MS, Senior Director, Research and Programs Patient-centered research and care focuses on outcomes that are most important to patients, which often are about how they […]
Recent NHC Comments Submitted to FDA & CMS
By Eric Gascho, NHC Vice President of Policy and Government Affairs The National Health Council frequently submits letters and comments on the administration’s rules and actions when its subjects are […]
Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out of Pocket Expenses
The National Health Council (NHC) appreciates the opportunity to respond to the Centers for Medicare & Medicaid Services’ (CMS’) Proposed Rule entitled “Modernizing Part D and Medicare Advantage to Lower […]